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H1 Hygiene System
EUDAMEDClass I (EU MDR)
Ref 108000003Model Cleaning and disinfection system
Identity
- Trade Name
- H1 Hygiene System EUDAMED
- Device Name
- H1 Hygiene System EUDAMED
- Model / Reference
- Cleaning and disinfection system EUDAMED108000003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D9841080000030 EUDAMED
- Basic UDI-DI
- ++D98410018KN EUDAMED
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Surgical utensil washer/disinfector
H1 Hygiene System by METASYS Medizintechnik GmbH — Class I — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical utensil washer/disinfector.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D98410018KN | Class I | Active |
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Manufacturer
- Manufacturer
- METASYS Medizintechnik GmbH
- EUDAMED SRN
- AT-MF-000014438
Sources (1)
- EUDAMED 9e814844-af94-4ae3-87b1-6afc739d6c6a 61 fields · synced Oct 7, 2026